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临床试验/NCT05960682
NCT05960682已完成不适用

French Translation and Validation of the Brief Index of Sexual Functioning for Men

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2023年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
1
主要终点
Response rate to the paper questionnaire

研究概览

简要总结

Sexual dysfunction consists of a disorder of the sexual response, either in terms of desire, or in terms of vasocongestion, or in terms of orgasmic response, or in more than one phase of this response :

Sexual dysfunctions are today described by the Diagnostic and Statistical Manual (DSM) V as:

  • Disorders of sexual desire or decreased libido
  • Sexual arousal disorder
  • Delayed or absent orgasmic disorder
  • Sexual disorder with pain Moreover, sexual dysfunctions are not without consequences on the life of a couple. The origins of these dysfunctions are multiple, but the result is most of the time the same: fear of failure, feeling of incompetence, anxiety, frustration or misunderstanding.

To date, the scientific community benefits from a few self-administered questionnaires to measure the impact of certain dysfunctions. None takes into account all the dimensions of male sexuality. In Italy, the Brief Index of Sexual Functioning for Men is used. This questionnaire contains 22 items, grouped into 7 areas exploring all of male sexuality: desire, arousal, frequency of activity, receptivity, pleasure/orgasm, relationship satisfaction, problem affecting sexuality. This questionnaire is not currently validated in French, whereas the Brief Index of Sexual Functioning for Women is validated.

详细描述

In this context, the Andrology Committee of the French Association of Urology wishes to create a pilot study with French patients presenting sexual dysfunctions with the aim of validating the questionnaire in French. Patient responses to each item will:

  • to determine if the formulation of the items is understandable by all, or if this is not the case
  • to identify the difficulties it can cause, and their causes. Patients treated for sexual dysfunction will be informed of the possibility of answering a questionnaire and that their data will be recorded for the purpose of studying practices and analyzing the results in an anonymous setting, and confidential via the delivery of the information leaflet dedicated to the study. They will have the opportunity to signify their refusal to participate without risk of modification of the coverage.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Adult patient with sexual dysfunction

排除标准

  • Patient refusing to participate
  • Patient with difficulties in understanding the French language.
  • Protected persons referred to in Articles L.1121-6 to L.1121-8 of the Public Health Code

结局指标

主要结局

Response rate to the paper questionnaire

时间窗: Day 1

Answer two sub-questions a) and b) after each item of the scale. These answers will allow to determine if the formulation of the items is understandable by all, or if this is not the case, to identify the difficulties it can cause, and their causes.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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